Contamination by production organism residual DNA
Plasmid DNA is frequently used in gene therapy and high purity plasmids are required. Residual DNA or proteins from the production organism (where plasmid was produced e.g. E. coli) are considered unacceptable contaminant.
Contamination by wild type virus in artificial drug virus
Viral vaccines or vectors are mostly prepared from wild type precursors, which lost their original activity. Artificial virus is less dangerous than wild type and has special characteristics. Wild type virus in a vaccine could have dangerous effect.
Viral contaminants in virus-free material
For the control of biological material it is necessary to check if the material does not contain any hazardous biological substance, such as virus.
Contamination tests on request development of method and subsequent validation can be included
The technology of dual-labeled hydrolysis probes (also called TaqMan® real-time PCR probes) exploits the 5 ́-3 ́ exonuclease activity of Taq DNA polymerase to cleave the probe. TaqMan real-time PCR probes are labeled with a fluorescent dye (reporter) at the 5´ end and with a quencher at the 3´ end.
Why choose alternative dyes instead of "genuine" dyes? First, they are cheaper, and second, they can give the same results. Another reason is that the number of suppliers who can provide modified oligonucleotides is restricted - only a patent or a licence owner is usually allowed to produce them.
Background Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. For instance, probiotics can be used in the treatment and prevention of infections and chronic inflammatory disorders of the gastrointestinal tract. Due to their health attributes, probiotics generate considerable interest in the area of functional
The avermectins compose a class of polycyclic lactones that are used to treat parasitic worms and insect pests. They are naturally occurring compounds generated in
a fermentation process by a soil actinomycete Streptomyces avermitilis.
Biodistribution (BD) studies are critical components when assessing the preclinical safety evaluation of cell and gene therapy molecules. BD analysis is generally conducted at the molecular level using a methodology that provides high sensitivity.